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临床试验/NCT07396610
NCT07396610已完成不适用

Comparative Evaluation of a Bioactive Glass Dentifrice and 810 nm Diode Laser for Dentinal Hypersensitivity: A Randomized Placebo-Controlled Clinical Study

King Khalid University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Change in Dentinal Hypersensitivity Pain Score

研究概览

简要总结

Dentinal hypersensitivity is a common clinical condition characterized by short, sharp pain arising from exposed dentin in response to thermal, tactile, or evaporative stimuli. It can significantly affect oral health-related quality of life and routine dental care. Various treatment approaches have been proposed, including laser therapy and bioactive materials, with differing mechanisms of action and clinical outcomes.

This randomized controlled clinical trial aims to compare the effectiveness of an 810-nm diode laser, a bioactive glass-based desensitizing agent, and a placebo in reducing dentinal hypersensitivity. Eligible participants with clinically diagnosed dentinal hypersensitivity will be randomly assigned to one of three parallel treatment groups. Pain intensity will be assessed using a visual analog scale following standardized air stimulus testing at baseline and at predefined follow-up intervals.

The study will evaluate both immediate and long-term changes in hypersensitivity over a 12-month follow-up period. The findings are intended to provide clinical evidence on the comparative performance of diode laser therapy and bioactive glass in the management of dentinal hypersensitivity.

详细描述

Dentinal hypersensitivity is a frequently encountered clinical condition characterized by a short, sharp pain arising from exposed dentin in response to thermal, tactile, osmotic, or evaporative stimuli. The condition is commonly associated with gingival recession, enamel loss, or dentin exposure due to abrasion, erosion, or periodontal therapy. Despite its high prevalence, the management of dentinal hypersensitivity remains challenging, and no single treatment approach has been universally accepted as the gold standard.

Conventional management strategies are primarily based on either neural desensitization or occlusion of dentinal tubules. Bioactive glass-based desensitizing agents, such as those containing calcium sodium phosphosilicate, act by releasing calcium and phosphate ions that form a hydroxycarbonate apatite-like layer, leading to physical occlusion of dentinal tubules. In contrast, diode laser therapy has been proposed to reduce dentinal hypersensitivity through mechanisms that may include alteration of nerve conduction, coagulation of dentinal proteins, and partial sealing of dentinal tubules. However, the comparative clinical effectiveness and durability of these treatment modalities remain unclear, particularly over long-term follow-up periods.

This randomized controlled clinical trial is designed to compare the effects of an 810-nm diode laser, a bioactive glass-based desensitizing agent, and a placebo intervention in the management of dentinal hypersensitivity. Eligible participants diagnosed with dentinal hypersensitivity based on clinical examination and positive response to standardized air stimulus testing will be randomly allocated into three parallel treatment groups. Randomization will be performed using an appropriate allocation method to ensure balanced group distribution.

Participants in the diode laser group will receive non-contact laser irradiation applied to exposed dentin surfaces using an 810-nm diode laser at a standardized power setting and exposure duration. Participants in the bioactive glass group will receive topical application of a bioactive glass-containing desensitizing agent according to manufacturer-recommended instructions. The placebo group will receive an inactive intervention designed to mimic the appearance and application procedure of the active treatments without containing therapeutic components.

Pain intensity will be assessed using a visual analog scale following standardized air stimulus testing. Outcome assessments will be conducted at baseline, immediately after treatment, and during follow-up visits at 1 month, 6 months, and 12 months. The primary outcome measure will be the change in dentinal hypersensitivity pain scores from baseline. Secondary outcomes will include the sustainability of pain reduction and participant-reported comfort over time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants are blinded to the assigned intervention. The diode laser, bioactive glass application, and placebo procedures are designed to appear similar to participants to minimize expectation bias. Outcome assessments are conducted using standardized protocols.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 to 60 years
  • Presence of clinically diagnosed dentinal hypersensitivity in at least one tooth
  • Positive response to standardized air stimulus test
  • Good general and oral health

排除标准

  • Presence of dental caries, defective restorations, or cracked teeth in the study tooth
  • Evidence of pulpal pathology or periapical disease
  • Periodontal disease requiring active treatment
  • Use of desensitizing agents or sensitivity treatments within the previous 4 weeks
  • History of allergy or hypersensitivity to any study materials
  • Systemic conditions or medications that may affect pain perception
  • Pregnant or lactating women

研究组 & 干预措施

Diode Laser Group

Experimental

Participants receive 810-nm diode laser therapy applied to hypersensitive dentin.

干预措施: 810-nm Diode Laser (Device)

Bioactive Glass Group

Experimental

Participants receive a bioactive glass-based desensitizing agent applied to hypersensitive dentin

干预措施: Bioactive Glass (NovaMin) (Drug)

Placebo Group

Placebo Comparator

Participants receive a placebo intervention without active desensitizing properties.

干预措施: Placebo (Other)

结局指标

主要结局

Change in Dentinal Hypersensitivity Pain Score

时间窗: Baseline, immediately after treatment, 1 month, 6 months, and 12 months

Change in pain intensity associated with dentinal hypersensitivity measured using a visual analog scale (VAS) following standardized air stimulus testing on the affected tooth.

次要结局

  • Sustained Reduction in Dentinal Hypersensitivity(6 months and 12 months)
  • Participant-Reported Comfort Level(1 month and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sunil Kumar Vaddamanu

Professor

King Khalid University

研究点 (1)

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